Bowel Obstruction SmallDASBONCT04750811
A Danish Audit of Small Bowel Obstruction
An observational study of Bowel Obstruction Small, run by Danish Small Bowel Obstruction Collaborative at 6 sites in Denmark.
Trial summary
Small bowel obstruction (SBO) is a common and potentially life-threatening acute surgical condition. A minority of patients present with a clear indication for urgent surgical intervention, either on the basis of clinical or radiological assessment (clinical signs of peritonitis/sepsis; suspicion of bowel ischaemia… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Obstruction Small
- How many people
- 540 participants
- Where
- 6 sitesDenmark
- Study dates
- 22 Feb 2021to 1 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to participating centres on the island of Sjaelland, Denmark
Who may be able to join
- Age ≥ 18 years old
- Radiological or clinical diagnosis of mechanical SBO
- Admitted to one of the 6 participating centres
Who cannot join
- SBO presenting within 30 days of a previous abdominal operation
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Denmark6 sites
Bispebjerg Hospital
Copenhagen, County, 2880
Herlev Hospital
Copenhagen
Hvidovre Hospital
Copenhagen
Hillerød Hospital
Hillerød
Zealand University Hospital
Køge
Slagelse Hospital
Slagelse
About this study
Small bowel obstruction (SBO) is a common and potentially life-threatening acute surgical condition. A minority of patients present with a clear indication for urgent surgical intervention, either on the basis of clinical or radiological assessment (clinical signs of peritonitis/sepsis; suspicion of bowel ischaemia; closed loop obstructions; irreducible herniae etc.). However, the optimal management of the remaining patients, the majority of whom present with SBO caused by abdominal adhesions, remains a topic of international debate with practice varying in different healthcare systems.
This multicentre, prospective, observational study aims to describe the current management of patients admitted with SBO in 6 acute hospitals (Bispebjerg, Herlev, Hillerød, Hvidovre, Køge, Slagelse) on the island of Sjælland, Denmark, which accounts for a 1/3 of the total Danish population.
Read the detailed description
This is a prospective, non-interventional observational study of the management and outcomes of patients admitted with SBO in Denmark.
Relevant clinicopathological demographics will be retrieved from consenting patients' medical records. An initial analysis will be performed once these patients have reached 90 days follow-up after the start of treatment. The long-term outcomes of treatment will be assessed with further analyses at 1, 3 and 5 years follow-up.
- Conditions
- Bowel Obstruction Small
- Keywords
- Small Bowel Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Small Bowel obstruction | Patients admitted with a diagnosis of small bowel obstruction at 1 of the 6 participating centres |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day morbidity rate
Measured: 30 days
30-day mortality rate
Measured: 30 days
Secondary outcomes (5)
90-day mortality rate
Measured: 90 days
To describe the proportion of patients undergoing operative versus non-operative management
Measured: From 90 days
To determine the success rate of non-operative management in patients with SBO and identify predictors of success/failure
Measured: From the start of treatment until 90-days follow-up
To determine the incidence and consequence of acute kidney injury in patients with SBO
Measured: 90 days
To determine the incidence and consequence of malnourishment in patients with SBO
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start22 Feb 2021
- Primary completion31 Aug 2021
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bowel Obstruction SmallStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Small Bowel Obstruction Collaborative
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henry Smith, Danish Small Bowel Obstruction Collaborative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04750811
- Sponsor's protocol ID
- P-2021-70
- Acronym
- DASBO
- Status last verified
- Mar 2024
- First submitted
- 3 Feb 2021
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mortensen MR, Alouda M, Bond Z, Burcharth J, Finne KF, Jensen TK, Lolle I, Malik T, Ngo-Stuyt L, Nielsen LBJ, Olausson M, Skovsen AP, Tolver MA, Smith HG. One-year outcomes following operative or non-operative management of adhesional small bowel obstruction. BJS Open. 2023 Sep 5;7(5):zrad103. doi: 10.1093/bjsopen/zrad103.
PubMed 37837353Tolver MA, AErenlund MP, Azzam M, Bjerke T, Burcharth J, Dibbern CB, Jensen TK, Jordhoj JQ, Lolle I, Ngo-Stuyt L, Nielsen EO, Nielsen LBJ, Olausson M, Skovsen AP, Smith HG. Inter-hospital variation in management of patients with small bowel obstruction in Denmark. Dan Med J. 2023 Aug 16;70(9):A01230057.
PubMed 37622641Olausson M, Aerenlund MP, Azzam M, Bjerke T, Burcharth JFH, Dibbern CB, Jensen TK, Jordhoj JQ, Lolle I, Ngo-Stuyt L, Nielsen EO, Nielsen LBJ, Skovsen AP, Tolver MA, Smith HG. Management and short-term outcomes of patients with small bowel obstruction in Denmark: a multicentre prospective cohort study. Eur J Trauma Emerg Surg. 2023 Apr;49(2):1121-1130. doi: 10.1007/s00068-022-02171-y. Epub 2022 Nov 10.
PubMed 36357790
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Danish Audit of Small Bowel Obstruction
- ClinicalTrials.gov ID
- NCT04750811
- Acronym / sponsor ID
- DASBO / P-2021-70
- Conditions
- Bowel Obstruction Small
- Keywords
- Small Bowel Obstruction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Danish Small Bowel Obstruction CollaborativeUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 11 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Small bowel obstruction (SBO) is a common and potentially life-threatening acute surgical condition. A minority of patients present with a clear indication for urgent surgical intervention, either on the basis of clinical or radiological assessment (clinical signs of peritonitis/sepsis; suspicion of bowel ischaemia; closed loop obstructions; irreducible herniae etc.). However, the optimal management of the remaining patients, the majority of whom present with SBO caused by abdominal adhesions, remains a topic of international debate with practice varying in different healthcare systems.
This multicentre, prospective, observational study aims to describe the current management of patients admitted with SBO in 6 acute hospitals (Bispebjerg, Herlev, Hillerød, Hvidovre, Køge, Slagelse) on the island of Sjælland, Denmark, which accounts for a 1/3 of the total Danish population.
Detailed description
This is a prospective, non-interventional observational study of the management and outcomes of patients admitted with SBO in Denmark.
Relevant clinicopathological demographics will be retrieved from consenting patients' medical records. An initial analysis will be performed once these patients have reached 90 days follow-up after the start of treatment. The long-term outcomes of treatment will be assessed with further analyses at 1, 3 and 5 years follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Small Bowel obstruction | – | –Patients admitted with a diagnosis of small bowel obstruction at 1 of the 6 participating centres |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to participating centres on the island of Sjaelland, Denmark
Key inclusion criteria (3 listed)
- Age ≥ 18 years old
- Radiological or clinical diagnosis of mechanical SBO
- Admitted to one of the 6 participating centres
Key exclusion criteria (1 listed)
- SBO presenting within 30 days of a previous abdominal operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
30-day morbidity rate
Time frame: 30 days
30-day mortality rate
Time frame: 30 days
5 secondary outcomes
90-day mortality rate
Time frame: 90 days
To describe the proportion of patients undergoing operative versus non-operative management
Time frame: From 90 days
To determine the success rate of non-operative management in patients with SBO and identify predictors of success/failure
Time frame: From the start of treatment until 90-days follow-up
To determine the incidence and consequence of acute kidney injury in patients with SBO
Time frame: 90 days
To determine the incidence and consequence of malnourishment in patients with SBO
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Derived from this study: PubMed 37837353Mortensen MR, Alouda M, Bond Z, Burcharth J, Finne KF, Jensen TK, Lolle I, Malik T, Ngo-Stuyt L, Nielsen LBJ, Olausson M, Skovsen AP, Tolver MA, Smith HG. One-year outcomes following operative or non-operative management of adhesional small bowel obstruction. BJS Open. 2023 Sep 5;7(5):zrad103. doi: 10.1093/bjsopen/zrad103.
- Derived from this study: PubMed 37622641Tolver MA, AErenlund MP, Azzam M, Bjerke T, Burcharth J, Dibbern CB, Jensen TK, Jordhoj JQ, Lolle I, Ngo-Stuyt L, Nielsen EO, Nielsen LBJ, Olausson M, Skovsen AP, Smith HG. Inter-hospital variation in management of patients with small bowel obstruction in Denmark. Dan Med J. 2023 Aug 16;70(9):A01230057.
- Derived from this study: PubMed 36357790Olausson M, Aerenlund MP, Azzam M, Bjerke T, Burcharth JFH, Dibbern CB, Jensen TK, Jordhoj JQ, Lolle I, Ngo-Stuyt L, Nielsen EO, Nielsen LBJ, Skovsen AP, Tolver MA, Smith HG. Management and short-term outcomes of patients with small bowel obstruction in Denmark: a multicentre prospective cohort study. Eur J Trauma Emerg Surg. 2023 Apr;49(2):1121-1130. doi: 10.1007/s00068-022-02171-y. Epub 2022 Nov 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bowel Obstruction Small, run by Danish Small Bowel Obstruction Collaborative at 6 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day morbidity rate (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04750811, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.